Glenmark Pharmaceuticals recalls Ciclopirox Gel 0.77% tubes due to broken seal complaints. This medication is for dermatological use only and requires a prescription. Affected products include 30g, 45g, and 100g tubes with specific NDC numbers.
Defective Container: Firm received complaints of broken tube at the seal.
Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes because customers reported broken seals. This medication is for skin use only and requires a prescription. If you have the recalled tubes, stop using them immediately as the broken seal could lead to improper application.
The tubes have a seal that can break, leading to potential leakage or contamination. This could cause improper application of the medication, but the product is designed for skin use only and not for eyes.
People with prescriptions for Ciclopirox Gel 0.77% who own the recalled tubes (30g, 45g, or 100g) are affected. Those using the product without a prescription or for eye application are not at risk.
Check for tubes labeled 'Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only'. The affected sizes are 30g, 45g, and 100g with NDC numbers 68462-0455-35, 68462-0455-47, and 68462-0455-94.
Look for the product name, size, and NDC numbers listed in the recall notice to confirm if your tube is affected.
If you have the recalled tubes, stop using them right away to avoid potential contamination or improper application.
No, this product is for dermatological use only and not for use in eyes. It requires a prescription.
The recalled tubes expire on April 30, 2026.
Check the tube label for the product name, size, and NDC numbers: 30g (NDC 68462-0455-35), 45g (NDC 68462-0455-47), or 100g (NDC 68462-0455-94).
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0002-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0002-2025 from Glenmark Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
